[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07437469":3,"trial-entities:NCT07437469":123,"trial-summary:NCT07437469":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":28,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":50,"secondary_outcomes":58,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":15,"eligibility_criteria":80,"std_ages":92,"locations":95,"central_contacts":114,"overall_officials":118,"references":121,"see_also_links":122},"NCT07437469","20251389","Binaural Beats for Postoperative Pain and Anxiety Reduction","Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled Trial","RECRUITING","2026-08-30","2026-04","2026-04-30","2026-03-09","University of Miami","OTHER",false,"To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).",null,[19,20,21,22,23,24,25,26,27],"TKA","THA","Anxiety","Binaural Beats","Music Exposure","Total Hip Arthroplasty (THA)","Total Knee Arthroplasty","Total Knee Replacement","Total Hip Replacement",[20,19,29,30,21,31,22,23],"Total hip arthroplasty","Total knee arthroplasty","Pain","INTERVENTIONAL","TREATMENT",[35],"NA",{"count":37,"type":38},50,"ESTIMATED",[40,45],{"type":14,"name":41,"description":42,"armGroupLabels":43},"Binaural Beats Audio Intervention","30-minute binaural beats audio session targeting 400 and 410 hertz (Hz) alpha 400 hertz (Hz) in one ear 410 hertz (Hz) in other ear frequency delivered through standardized headphones in the PACU.",[44],"Binaural Beats (BB)",{"type":14,"name":46,"description":47,"armGroupLabels":48},"Music of Choice","Usual postoperative care in addition to patient-selected music using standardized headphones",[49],"Music of Choice (MOC)",[51,55],{"measure":52,"description":53,"timeFrame":54},"Change in Pain Score Numeric Pain Rating Scale (NPRS)","Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where 0 = no pain and 10 = worst imaginable pain. Change will be calculated as the difference between the pre-operative NPRS score and the NPRS score obtained 4 hours after surgery. Higher scores indicate greater pain intensity.","Baseline (pre-operative) to 4 hours post-operation.",{"measure":56,"description":57,"timeFrame":54},"Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)","Anxiety will be measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, producing a total score range of 20-80, with higher scores indicating greater state anxiety. Change will be calculated as the difference between the pre-operative STAI-S score and the STAI-S score obtained 4 hours after surgery.",[59,63,67,71,74],{"measure":60,"description":61,"timeFrame":62},"Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)","Total opioid use administered during the post-anesthesia care unit (PACU) stay will be recorded, including all intravenous and oral opioid medications. All doses will be converted to morphine milligram equivalents (MME) using standard Centers for Disease Control and Prevention (CDC) conversion factors. Unit of Measure: Morphine milligram equivalents (MME)","From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)",{"measure":64,"description":65,"timeFrame":66},"Postoperative Vital Signs Heart Rate","Heart rate (beats per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.","Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).",{"measure":68,"description":69,"timeFrame":70},"Patient Satisfaction Score","Patient satisfaction with the postoperative experience will be measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. Unit of Measure: Likert score (1-5)","Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation",{"measure":72,"description":73,"timeFrame":66},"Postoperative Vital Signs Blood Pressure","Systolic and diastolic blood pressure (millimeters of mercury) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.",{"measure":75,"description":76,"timeFrame":66},"Postoperative Vital Signs Respiratory Rate","Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.","ALL","18 Years","99 Years",{"inclusion":81,"exclusion":86,"raw_text":91},[82,83,84,85],"American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3","Spinal anesthesia","Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)","Primary total hip or total knee arthroplasty",[87,88,89,90],"Moderate-severe hearing impairment or use of hearing aids","History of significant tinnitus, active delirium, chronic high-dose opioid therapy (\\>60 MME\u002Fday baseline)","Major psychiatric pathology","General anesthesia","Inclusion Criteria:\n\n* American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3\n* Spinal anesthesia\n* Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)\n* Primary total hip or total knee arthroplasty\n\nExclusion Criteria:\n\n* Moderate-severe hearing impairment or use of hearing aids\n* History of significant tinnitus, active delirium, chronic high-dose opioid therapy (\\>60 MME\u002Fday baseline)\n* Major psychiatric pathology\n* General anesthesia",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":111},"Univeristy of Miami Health System","Miami","Florida","33132","United States",[103,108],{"name":104,"role":105,"phone":106,"email":107},"Andrew R Moya, MD","CONTACT","786-856-6463","arm577@miami.edu",{"name":109,"role":110},"Victor H Hernandez, MD","PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},25.77427,-80.19366,[115],{"name":104,"role":105,"phone":116,"email":117},"1786-856-6463","arm577@miami.edu, doc.a.moya1@gmail.com",[119],{"name":120,"affiliation":13,"role":110},"Victor H Hernandez, MD, MSc",[],[],{"nct_id":4,"conditions":124,"biomarkers":126},[26,125],"Total replacement of hip",[],{"nct_id":4,"found":128,"summary":129,"prompt_version":139},true,{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is an interventional study planning to enroll 50 participants. It compares two different audio interventions.","completed","Binaural Beats for Postoperative Pain and Anxiety","This study is looking at whether listening to \"Binaural Beats Audio Intervention\" can help reduce pain and anxiety after surgery. It compares this audio intervention to listening to your \"Music of Choice\" after total knee arthroplasty (TKA) or total hip arthroplasty (THA) surgery. Researchers will measure your pain and anxiety levels before surgery and again up to 4 hours after. You might be able to join if you are between 18 and 99 years old, are having TKA or THA surgery, and meet certain health criteria. The study aims to enroll 50 participants, but its current status is unclear.","Your pain and anxiety will be measured up to 4 hours after your operation.",99,"You would receive a 30-minute audio session in the Post-Anesthesia Care Unit (PACU) and have your pain and anxiety measured before surgery and up to 4 hours after.","Not stated in the trial record.",[41,46],"v2"]